drugmakers continue 'off-label marketing' despite large fines.”
In the last year, Pfizer agreed to pay $2.3 billion as settlement for allegations of illegal promotion of the arthritis med Bextra (pulled from the market) and other meds. Meanwhile, Eli Lilly agreed to pay $1.4 billion to settle criminal and civil charges for its off-label marketing of the antipsychotic med Zyprexa.
Around the same time, Johnson&Johnson’s Ortho-McNeil got slapped on the wrist for $6.4 million for its off-label promotion of the anti-seizure med Topamax for bipolar and other uses. The article mentions that the company paid physicians as much as $3,000 to accompany sales reps on doctor visits to “talk to you about things [the sales rep] can’t talk to you about.”
Earlier this year, Astra-Zeneca coughed up $18 million for marketing the antipsychotic Seroquel off-label to children and dementia patients.
Doing the math indicates that breaking the law is very good business practice. In 2004, Pfizer agreed to pay out $430 million for promoting the anti-seizure med Neurontin for bipolar and pain. Between 1999 and 2004, the drug raked in $10 billion in off-label sales.
Neurontin failed two clinical trials for treating bipolar. The drug itself may not have been harmful per se, but by promoting what was in effect a placebo with side effects the company was knowingly putting bipolar patients in harm’s way.
Thankfully, the Star-Ledger’s account stuck to the facts, which alone amounted to a ringing indictment on the drug industry. Too often, we see these stories in a far more emotional (and highly inaccurate) context, so let’s briefly re-examine some of the issues, which I have extensively reported on here and on mcmanweb and in my Newsletter and elsewhere:
The drug industry’s marketing practices are highly shameful. No question about it. This is where Enron meets BP meets Detroit. The industry, with the acquiescence of psychiatry, has been pulling one over on doctors, patients, and loved ones for years. I could write a book on this. Other people have.
The drug industry sets the agenda for psychiatry. Yes-no-maybe. Until a few years ago, this would have been a strong yes. But then, as patents for blockbuster meds began expiring and with no new meds (not just “me too” meds) coming on-stream, the drug companies lost interest in influencing psychiatry. “Ubiquity” is a term that no longer applies to drug companies, and thanks to new economic realities may never again.
At the same time, doctors and patients and loved ones, including the organizations that speak for them, have wised up. Fool me once ...
If a drug does not have FDA approval for a particular use, then it is dangerous for physicians to prescribe it for that use. Blatantly false. As Stephen Stahl of UCSD pointed out at an APA meeting: “The FDA regulates the sale of medicine, not the practice of medicine.”
FDA indications tend to be the end result of company marketing strategies, which figured into Eli Lilly and others initially seeking depression indications for their SSRIs, even though this class of drugs appears to work better for anxiety. Only later did these companies seek approval for the treatment of anxiety. So, was their “off-label” use in the interim bad medicine? Hardly.
As former head of the NIMH Frederick Goodwin pointed out at an APA meeting, new uses for meds are typically discovered and championed by clinicians in practice. The drug companies only come to the party later. If we were at the mercy of drug companies taking the initiative, bipolar patients would still be waiting for lithium, anti-seizure meds, and antipsychotics (there is not a single bipolar med developed by a drug company from scratch).
Despite this, the NY Times and other publications routinely (and ignorantly) equate off-label meds to rogue medicine.
“Powerful” drugs must be harmful drugs. Totally false. You will often read this in the context of doctors prescribing “powerful” antipsychotics” (off-label, of course) to kids for the “controversial” diagnosis of bipolar. Meds are supposed to be powerful. If you have any doubts about this, simply ask for a “weak” pain-killer next time your back gives out on you.
“Controversial” diagnoses (such as early-onset bipolar) have been manufactured by the drug companies to create new markets. Absurdly false. In this regard, the NY Times and other publications are difficult to distinguish from antipsychiatry diatribes. Academic food fights do exist, but hardly constitute evidence of fundamental splits of opinion. With regard to early onset bipolar, the diagnosis was promoted by - of all things - beleaguered parents educating disbelieving clinicians.